UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053615 |
|---|---|
| Receipt number | R000061186 |
| Scientific Title | Comprehensive survey of initial experiences with endoscopic ultrasound-guided biliary drainage |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2024/02/14 23:10:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comprehensive survey of initial experiences with endoscopic ultrasound-guided biliary drainage
Acronym
Comprehensive survey of initial experiences with endoscopic ultrasound-guided biliary drainage
Scientific Title
Comprehensive survey of initial experiences with endoscopic ultrasound-guided biliary drainage
Scientific Title:Acronym
Comprehensive survey of initial experiences with endoscopic ultrasound-guided biliary drainage
Region
| Japan |
Condition
Condition
Malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the feasibility and safety of EUS-BD based on comprehensive data from non high-volume centers in order to understand the current status of EUS-BD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical success and AEs rates
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients after EUS-BD for malignant biliary obstruction
Key exclusion criteria
After the first 20 cases at participating institutions within the observation period
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ishida |
Organization
Fukuoka University
Division name
Department of Gastroenterology and Medicine, Faculty of Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
0928011011
takehikoga@gmail.com
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Koga |
Organization
Fukuoka University
Division name
Department of Gastroenterology and Medicine, Faculty of Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
09083917399
Homepage URL
takehikoga@gmail.com
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
n/a
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
Tel
092 801 1011
fumed-ethics@fukuoka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multi-center retrospective study
Management information
Registered date
| 2024 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061186
